Cha Jiyun, Kim Sungha, Kim Pyung-Wha, Lee Hesol, Ko Mi Mi, Jang Soobin, Lee Myeong Soo
Digital Health Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Department of Internal Korean Medicine, College of Korean Medicine, Daejeon University, Daejeon, South Korea.
Front Pharmacol. 2022 Apr 25;13:868662. doi: 10.3389/fphar.2022.868662. eCollection 2022.
We developed a Korean medicine core outcome set for stroke sequelae (COS-SS-KM) to evaluate the effectiveness and safety of herbal medicine (HM) for stroke sequelae, especially for elderly stroke patients in primary clinics. We identified previously reported outcomes from a literature review and defined the list of outcomes and effect modifiers for the core outcome set (COS) questionnaire. Three rounds of modified Delphi consensus exercises with experts were conducted online for suitability assessment, and one round of a modified Delphi consensus exercise with primary clinicians was conducted for feasibility assessment. The review identified 17 outcomes and 16 effect modifiers; moreover, six outcomes and one effect modifier were suggested by the experts. The final COS comprised 8 outcomes and 12 effect modifiers for history taking, and experts listed 13 major symptoms of stroke sequelae for symptom assessment. The clinicians agreed on the feasibility of the COS. This COS will help primary care researchers assess the effectiveness of pharmacotherapy, including HM, for elderly patients with stroke sequelae. Future studies should focus on reflecting the opinions of all stakeholders.
我们制定了一个中风后遗症的韩医核心结局集（COS-SS-KM），以评估草药（HM）对中风后遗症的有效性和安全性，特别是针对基层诊所的老年中风患者。我们通过文献综述确定了先前报道的结局，并定义了核心结局集（COS）问卷的结局和效应修饰因素列表。针对适宜性评估，与专家进行了三轮在线改良德尔菲共识练习，针对可行性评估，与基层临床医生进行了一轮改良德尔菲共识练习。该综述确定了17个结局和16个效应修饰因素；此外，专家们还提出了6个结局和1个效应修饰因素。最终的COS包括8个用于病史采集的结局和12个效应修饰因素，专家们列出了13个中风后遗症的主要症状用于症状评估。临床医生认可了COS的可行性。这个COS将有助于基层医疗研究人员评估包括HM在内的药物治疗对老年中风后遗症患者的有效性。未来的研究应注重反映所有利益相关者的意见。
